NCT01335867.
Trial name or title | A phase II, double‐blind, placebo‐controlled, pilot trial of vigabatrin for the treatment of cocaine and alcohol dependence |
Methods | Randomised, double‐blind, placebo‐controlled trial |
Participants | 38 |
Interventions | Vigabatrin or placebo |
Outcomes | Primary outcomes: Reduction in cocaine use (number of benzoylecgonine (BE)‐negative urine samples); Alcohol abstinent days and heavy drinking days, recorded using the Timeline Followback method Secondary outcomes: Measures of cocaine and alcohol craving, measured using the Minnesota Cocaine Craving Scale and the Penn Alcohol Craving Scale; Addiction severity by the Addiction Severity Index (ASI); Disease severity and improvement, including the Clinical Global Impression Scale; Alcohol and cocaine withdrawal severity, including the Clinical Institutes Withdrawal Scale for Alcohol and Cocaine Selective Severity Assessment; Depression and anxiety, using the Hamilton Depression Rating Scale and the Hamilton Anxiety Rating Scale |
Starting date | April 2011 |
Contact information | Treatment Research Center, Philadelphia, PA 19104 USA |
Notes |